OXY-GENERATOR— 510(k) K941145

Substantially Equivalent

Med Systems

FDA 510(k) clearance K941145 for OXY-GENERATOR, Substantially Equivalent on 1995-09-27. Applicant: Med Systems.

Clearance details

Applicant: Med Systems
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1994-03-10
Decision date: 1995-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

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Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.